Safety, tolerability, food effect and pharmacokinetics of FT011 in healthy volunteers and patients with Type 2 diabetes-associated diabetic nephropathy

Phase 1

Completed

• Conditions: Diabetic nephropathy; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12613000386730
• Lead Sponsor: Fibrotech Therapeutics Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 80

Inclusion Criteria

Healthy volunteers (Part A, Part B, Part C):
- Male aged 18 to 45 years old inclusive
- Good general health without clinically significant medical history
- Body mass index < 30

Patients (Part C):
- males aged 18 to 70 years old inclusive
- have Diabetes Mellitus Type 2
- have overt albuminuria
- have eGFR >/= 30 and < / = 60 mL/min
- currently taking either an ACEi or an ARB at a stable dose.

Exclusion Criteria

Healthy volunteers (Part A, Part B, Part C):
- Have received any investigational research agent within 30 days or 5 half-lives (whichever is longer) prior to the first dose, or an investigational vaccine within 6 months, a live attenuated vaccine within 60 days or a registered vaccine within 30 days prior to the first dose of the Investigational Product.
- Have a history of thyroidectomy or thyroid disease that required medication within the past 12 months.
- Have had serious angioedema episodes within the previous 3 years or requiring angioedema medication in the previous two years.
- Have a bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with blood draws.
- Have any clinically significant abnormality at Screening (determined by medical history, physical examination, blood chemistry, haematology, urinalysis and a 12-lead ECG, or positive urine screen for drugs of abuse), a psychiatric condition that precludes compliance with the protocol, or any other condition which in the view of the Investigator is likely to interfere with the study or put the subject at risk.
- Have a history of or current clinically significant gastrointestinal, hepatic, renal, cardiovascular, respiratory, endocrine, oncological, immunodeficiency, neurological, metabolic, haematological or autoimmune disorder; or a history of or current tuberculosis, epilepsy, diabetes or glaucoma

Patients (Part C):
- Have a history of untreated or uncontrolled proliferative or pre-proliferative diabetic retinopathy
- Have evidence of hepatic dysfunction, HbA1c > 11.0%, serum potassium > 6 mmol/L.
- Have untreated urinary tract infection or other medical conditions that impact urinary protein values
- Have unstable angina pectoris or New York Heart Association Class III or IV congestive heart failure.
- Have a history of any major medical condition or any condition which in the view of the Investigator is likely to interfere with the study or put the subject at risk.
- Have any risk of bleeding
- Use of anticoagulant drugs including warfarin or heparin, low molecular weight heparin, danaparoid, hirudin, or others.
- Have other specific renal conditions known to be the cause of renal disease, and patients with other specific, clinically significant renal disease.
- Have a history of or current clinically significant gastrointestinal, hepatic, renal, cardiovascular, respiratory, endocrine, oncological, immunodeficiency, neurological, metabolic, haematological or autoimmune disorder; or a history of or current tuberculosis, epilepsy, diabetes or glaucoma.

Study & Design

• Study Type: Interventional
• Study Design: Not specified